FDA 510(k) Application Details - K142657

Device Classification Name Saliva, Artificial

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510(K) Number K142657
Device Name Saliva, Artificial
Applicant BIO COSMETICS, S.L.
CALLE ARAQUIL, 11
MADRID 28023 ES
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Contact SUSANA SARDON
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Regulation Number 000.0000

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Classification Product Code LFD
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Date Received 09/18/2014
Decision Date 09/14/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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